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FDA establishment 3002964398, Aizuwakamatsu, Japan. Part of Aizu Olympus's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 4
Official action indicated: 1
Last inspection ended: Jul 8, 2022
Warning letters: 1
Import refusals since 2024: 24
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
21 CFR 803.52(c)(3). Manufacturer Name and Address An individual medical device manufacturer report submitted per Form FDA 3500A format did not contain in Block D the device manufacturer's name and address.
21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Aizuwakamatsu, Japan. Part of